CN102196778B - Systems and methods for internal bone fixation - Google Patents

Abstract

Internal bone fixation devices and methods for using the devices for repairing a weakened or fractured bone are disclosed herein. According to aspects illustrated herein, there is provided a device (700) for repairing a fractured bone that includes a delivery (710) having an elongated shaft (701) with a proximal end, a distal end, and a longitudinal axis therebetween, the delivery catheter (710) having an inner void (713) for passing at least one reinforcing material, and an inner lumen (711) for accepting a light pipe (652), wherein a distal end (723) of the inner lumen (711) terminates in an optical lens (754); a conformable member (703) releasably engaging the distal end of the delivery catheter (710), the conformable member (703) moving from a deflated state to an inflated state when the at least one reinforcing material is delivered to the conformable member (703); and an adapter releasably engaging the proximal end of the delivery catheter (710) for receiving the light pipe (652) and the at least one reinforcing material.

Description

For the fixing system and method for inner skeleton

Technical field

Embodiment disclosed herein relates to the medical treatment device that weakens skeleton or fractured bones for repairing, and more specifically, relates to inner skeleton fixture and repairs the method that weakens skeleton or fractured bones with these devices.

Background technology

Fracture repair is the process of being rejoined in the end of fractured bone and again aiming at.In the time need to recovering the normal position of fractured bone and function, just need to carry out fracture repair.In the whole process in union of fracture stage, skeleton firmly must be held in the correct position and support, until it is enough strong in taking the weight of.Not rightly repair of bone fractures in the situation that, may there is the dislocation of skeleton, thereby cause the possible body function obstacle in skeleton or that joint, region of health.

Until last century, doctor relies on mould and clamping plate from external support skeleton (external stability).But the development of aseptic operation has reduced the risk infecting, therefore doctor can directly process skeleton, and material can be implanted.There are at present some to repair, strengthen and support the internalist methodology of fractured bones.They comprise use internal fixing device, and for example steel wire, plate, rod, pin, nail and screw directly support skeleton, and bone cement mixture or skeleton infilling are added in fractured bones.

Bone cement is added in fractured bones for repairing skeleton, and for example connects skeleton, this is well-known in prior art.Traditional bone cement injection device is difficult to adjust in real time or control in response to the spongy bone volume running in fractured bones inside and density situation injection volume or the charge velocity of bone cement.Traditional bone cement also may cause complicated, and this comprises the perimeter seepage of bone cement to fractured bones position, and this seepage can cause damage and radiculalgia and the contraction of soft tissue.

Like this, this area needs inner skeleton fixture, and fractured bones can be repaired, strengthen and support to this device by less invasive techniques, and this device is easy to use, and for the injury minimum of skeleton and supporting tissue.

Summary of the invention

Herein disclosed is inner skeleton fixture and repair the method that weakens skeleton or fractured bones with these devices.According to illustrated herein aspect, device for repair of bone fractures skeleton is provided, this device comprises: the delivery conduit with slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of light pipe, and the far-end of wherein said interior lumen ends at optical lens; Conformal member, described conformal member engages the far-end of delivery conduit in detachable mode, and wherein, in the time that at least one reinforcement material is transported to described conformal member, conformal member moves to swelling state from contraction state; And adapter, described adapter engages the near-end of delivery conduit in detachable mode, for receiving described light pipe and described at least one reinforcement material.

According to illustrated herein aspect, device for repair of bone fractures skeleton is provided, this device comprises: the delivery conduit with slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, and described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of optical fiber; Conformal member, described conformal member engages the far-end of delivery conduit in detachable mode, described conformal member has the interior lumen that receives described optical fiber, wherein, in the time that at least one reinforcement material is transported to described conformal member, conformal member moves to swelling state from contraction state; And adapter, described adapter engages the near-end of delivery conduit in detachable mode, for receiving described optical fiber and at least one reinforcement material.

According to illustrated herein aspect, the method for repair of bone fractures skeleton is provided, it comprises: the inner chamber that enters fractured bones; Be provided for repairing the device of described fractured bones, described device comprises: delivery conduit, described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of optical fiber, described delivery conduit engages conformal member in detachable mode, and described conformal member has the interior lumen as the passage of described optical fiber; Described conformal member is positioned to at least two skeleton sections crossing over described fractured bones; Described optical fiber is inserted in the interior lumen of described conformal member; Introduce described at least one reinforcement material described reinforcement material is injected in described conformal member by the internal voids of described delivery conduit, wherein said conformal member moves to swelling state from contraction state; Activate the light source being connected with described optical fiber to transmit the interior lumen of luminous energy to described conformal member, thereby make at least one reinforcement material sclerosis; With by sclerosis conformal member remove from described delivery conduit.

Preferably, device also comprises the light source for luminous energy is provided to described optical fiber, and wherein said optical fiber is dispersed described luminous energy at the terminal area of described optical fiber.

Preferably, device also comprises the light source for luminous energy is provided to described optical fiber, and wherein said optical fiber is dispersed described luminous energy along at least a portion of described fiber lengths.

Preferably, wherein disperse luminous energy by the surface of modifying described optical fiber along described fiber segment.

Preferably, wherein light source provides luminous energy to described optical fiber, and described optical fiber is dispersed described luminous energy at the terminal area of described optical fiber.

Preferably, wherein light source provides luminous energy to described optical fiber, and described optical fiber is dispersed described luminous energy along at least a portion of described fiber lengths.

Preferably, wherein disperse described luminous energy by the surface of modifying described optical fiber along described fiber segment.

Brief description of the drawings

With reference to the accompanying drawings disclosed embodiments of the present invention are further explained, wherein in these views, similar structure represents by identical numeral.Shown accompanying drawing might not be pro rata, and its emphasis is placed on above the principle of explanation disclosed embodiments of the present invention conventionally.

Fig. 1 show in disclosed embodiments of the present invention for repairing the perspective view of the device that weakens skeleton or fractured bones.

Fig. 2 A-2B show in disclosed embodiments of the present invention for repairing the perspective view of device of the Fig. 1 that weakens skeleton or fractured bones.Fig. 2 A shows the capsule part of the device in contraction state.Fig. 2 B shows the capsule part of the device in swelling state.

Fig. 3 A-3 show in disclosed embodiments of the present invention for repairing the close up view of some critical pieces of the device that weakens skeleton or fractured bones.Fig. 3 A shows the perspective view of this device far-end.Fig. 3 B shows the side sectional view of this device A-A along the line.Fig. 3 C shows the cutaway view of this device B-B along the line.

Fig. 4 show with in disclosed embodiments of the present invention for repairing the perspective view of embodiment of the light pipe using together with the device that weakens skeleton or fractured bones.

Fig. 5 A-5B show in disclosed embodiments of the present invention for repairing the cutaway view of embodiment of the device that weakens skeleton or fractured bones.Fig. 5 A shows the side sectional view of the device with described light pipe of Fig. 4.Fig. 5 B shows the cutaway view of this device.

Fig. 6 show with in disclosed embodiments of the present invention for repairing the perspective view of embodiment of the light pipe using together with the device that weakens skeleton or fractured bones.

Fig. 7 show in disclosed embodiments of the present invention for repairing the side sectional view of embodiment of device of the light pipe with Fig. 6 that weakens skeleton or fractured bones.

Fig. 8 show with in disclosed embodiments of the present invention for repairing the perspective view of illustrative embodiment of the optical fiber using together with the device that weakens skeleton or fractured bones.

Fig. 9 A-9E shows the close-up perspective view of the illustrative embodiment of the modification of a part for the optical fiber in disclosed embodiments of the present invention.

Figure 10 A-10E shows the device utilizing in disclosed embodiments of the present invention carrys out the method step of repair of bone fractures skeleton.

Figure 11 A-11C shows the illustrative embodiment of the fracture metacarpal bone in the finger of hands.

Figure 12 A-12C shows the device of the disclosed embodiments of the present invention fixing for inner skeleton.The placement of this device when Figure 12 A shows the metacarpal fracture of patient's hands.Figure 12 B shows and expands by reinforcement material so that the side view of the capsule part of this device when repair of bone fractures when capsule part.Figure 12 C shows after capsule part being removed from this device the side view in the capsule part of skeleton fracture.

Although above-mentioned definite accompanying drawing has provided disclosed embodiments of the present invention, also it is contemplated that other embodiment, indicated in discussing.By typical case, nonrestrictive mode has provided illustrative embodiment in the present invention.Those skilled in the art can contemplate many other modification and and embodiment, and they fall in the scope and spirit of principle of disclosed embodiments of the present invention.

Detailed description of the invention

Herein disclosed is the medical apparatus and the method that weaken skeleton or fractured bones for repairing.Device disclosed herein is used as inner skeleton fixture, and comprises the delivery conduit with the slender axles that end at detachable conformal member.In the process for repair of bone fractures skeleton, conformal member is placed in the inner chamber of fractured bones with contraction state.Once be positioned at tram, conformal member is expanded to swelling state by adding at least one reinforcement material from contraction state.Make subsequently to use up at least one reinforcement material sclerosis making in conformal member, described light is advanced and disperses from be arranged on the light pipe in the light pipe conduit of this device.The light source that engages this light pipe provides the described reinforcement material of sclerosis required light.In one embodiment, light pipe is arranged on the separation junction point in this device so that reinforcement material hardens, and described separation abutment is the region between detachable conformal member and the slender axles of delivery conduit.In one embodiment, light pipe is arranged in this device to this light pipe is introduced and in the interior lumen of conformal member, makes reinforcement material sclerosis.Then the conformal member of this sclerosis can be from delivery conduit dismounting sealed, to this at least one reinforcement material is enclosed in conformal member.The conformal member of this sclerosis is retained in the interior intracavity of fractured bones, and provides support and correct location to fractured bones, thereby makes fractured bones can repair, heal and strengthen.

Reinforcement material includes but not limited to, skeleton fortified mixture (for example bone cement mixture, skeleton infilling, epoxy resin, glue and similar binding agent), orthopaedic line, stainless steel bar, metal pin and other similar device.Reinforcement material can be the natural or synthetic material for strengthening, replace or strengthen skeleton or osseous tissue.Skeleton fortified mixture comprises glue, binding agent, cement, hard tissue substituting polymer, biodegradable polymer (for example PLA, PGA and PLA-PGA copolymer), natural coral, hydroxyapatite, bata-tricalcium phosphate and well known in the art for strengthening, replace or strengthen the various other biological materials of skeleton.As inert material, skeleton fortified mixture can merge in surrounding tissue, or is substituted gradually by original structure.Those skilled in the art will recognize that, many skeleton fortified mixture well known in the art are all in the spirit and scope of disclosed embodiments of the present invention.

Device disclosed herein can be used for repairing and cause due to skeletal diseases arbitrarily weakening or the skeleton of fracture, these skeletal diseases include but not limited to, osteoporosis, achondroplasia, osteocarcinoma, fibrodysplasia ossificans progressiva, fiber are abnormal, childhood lopsided property osteochondritis, myeloma, osteogenesis imperfecta, osteomyelitis, periostitis, osteoporosis, osteitis deformans (Paget ' s disease), skoliosis and other similar disease.Device disclosed herein can be used for repairing due to the wound skeleton that weakens or fracture causing of for example falling.

Although fractured bones is shown in some figure to the palm bone of hands, but those skilled in the art will recognize that disclosed apparatus and method can be for repairing other skeletons, include but not limited to, femur, tibia, fibula, humerus, ulna, radius, middle bone, phalanges, phalanx, rib, spine, vertebra, clavicle and other skeletons, and they are all in the scope and spirit of disclosed embodiment.

The critical piece that is used for the embodiment of repairing the device that weakens skeleton or fractured bones is totally presented at Fig. 1 and Fig. 2 A and Fig. 2 B.Device 100 comprises the delivery conduit 110 with slender axles 101, and these slender axles 101 have near-end 102, far-end 104 and the longitudinal axis between far-end and near-end.In one embodiment, the diameter of delivery conduit 110 is approximately 3mm.The far-end 104 of delivery conduit 110 ends at detachable conformal member 103 (herein also referred to as capsule part).In the time that at least one reinforcement material is transported to capsule part 103, capsule part 103 can move to swelling state (Fig. 2 B) from contraction state (Fig. 2 A).In one embodiment, capsule part 103 has the contracted diameter of about 2.5mm.In one embodiment, to have scope be the swell diameter from about 4mm to about 9mm to capsule part 103.Reinforcement material can be transported to capsule part 103 via the internal voids that can allow reinforcement material to pass through.In one embodiment, for example ultraviolet light activation glue of reinforcement material is used to make capsule part 103 expand and shrink. and in one embodiment, capsule part 103 can be shape circle, flat, columniform, oval-shaped, rectangle or other.Capsule part 103 can be made up of flexible, resilient, the conformal material with firm, and described material includes but not limited to urethanes, polyethylene terephthalate (PET), nylon elastomer and other similar polymer.In one embodiment, capsule part 103 is made up of PET nylon aramet or other non-expendable materials.PET is the thermoplastic polymer resin for the synthesis of the Ju Cu family of fiber.According to its course of processing be subject to thermal history, PET to can be used as noncrystalline and those semi-crystalline materials to exist.Hypocrystalline PET has good intensity, ductility, rigidity and hardness.Noncrystalline PET has better ductility, but rigidity and hardness are poor.PET can be semi-rigid to rigidity according to its thickness, and very light in weight.PET is firm and impact-resistant, natural colourless and transparent, and mineral oil, solvent and acid are had to good repellence.

In one embodiment, capsule part 103 is designed to the inwall of the cavity in even contact skeleton.In one embodiment, capsule part 103 can have predetermined shape, to be fitted in the cavity of given shape skeleton.For example, as shown in the embodiment of Fig. 1, the reservation shape of capsule part 103 can be longilineal cylinder.Capsule part 103 has near-end 123, far-end 121 and the longitudinal axis with outer surface 122 between far-end and near-end.The outer surface 122 of capsule part 103 is smooth and level and smooth substantially, and substantially coordinates with the wall of the cavity in skeleton.In one embodiment, the outer surface 122 of capsule part 103 is not all level and smooth, but may have some small embossment or projection/pits along its length.In some embodiments, do not have large ledge outstanding from the outer surface 122 of capsule part 103.Capsule part 103 can be designed as in the cavity that remains on skeleton, and can not stretch out by any hole or seam in skeleton.In one embodiment, the outer surface 122 of capsule part 103 can be concordant with cavity wall, and in the time that capsule part 103 expands, outer surface 122 can be along at least a portion contact cavity wall of surf zone.In one embodiment, in the time that capsule part 103 expands, the outer surface 122 of capsule 103 most of or all do not contact cavity wall and any hole that can be from skeleton or seam in extend through.

The outer surface 122 of capsule part 103 can be coated with for example material of medicine, osseocolla, protein, somatomedin or other coatings.For example, after minimal invasive surgical procedures, patient may be infected, and this just requires patient to carry out antibiotic therapy.Antibiolics can be added on the outer surface 122 of capsule part 103, to prevent or to resist possible infection.Such as for example protein of skeleton shaping protein or other somatomedin, show to bring out the generation of soft bone and bones.Somatomedin can be added on the outer surface 122 of capsule part 103, to help to bring out the generation of new bone.Because the reinforcement material in capsule part 103 can thermal output, therefore can keep effectiveness and the stability of coating.

In one embodiment, the outer surface 122 of capsule part 103 can be rib, ridge, projection or other shapes, to contribute to capsule part 103 to meet the shape of bone cavity.Capsule part can be configured to cross the tube chamber of skeleton, and expansion, disposal and removing obturator.Like this, capsule part 103 can more easily be slided in tube chamber, and does not contact with surrounding tissue.Capsule part 103 also can design to use to be had the grain surface of various shape (for example little ridge or rib) and is placed in skeleton and grasps fractured bones and without any slip.

In one embodiment, on the outer surface 122 of capsule part 103, apply water-soluble glue.In the time that capsule part 103 is expanded and engage wet bone, the water-soluble glue on the outer surface 122 of capsule part 103 becomes thickness or very sticky, and plays and firmly grasp the effect of member to increase the conformal combination of capsule part 103 to skeleton.Once capsule part 103 expands, the promptly skeleton of outer surface 122 of capsule part 103, thus form mechanical bond and chemical bond.These are in conjunction with the probability that has prevented that skeleton from sliding.Water-soluble glue can be passed through any light (for example, and do not require it is ultraviolet) and solidify.

In one embodiment, capsule part 103 has grain surface, and this grain surface provides one or more ridges, and described ridge can grasp all parts of the bone fragments of fractured bones.In one embodiment, ridge is around capsule part 103, and is designed to increase grasping fractured bones in the time that the capsule part 103 expanding contacts with fractured bones.Ridge is also compressible, thereby these ridges can fold in fractured bones in the time of 103 complete expansion of capsule part.In one embodiment, the sand blasted surface on the outer surface 122 of capsule part 103 is improved connection and the adhesion between outer surface 122 and the inner skeleton of capsule part 103.The size of the surf zone contacting with skeleton has been improved on this surface significantly, thereby forms more fastening promptly effect.

The capsule part 103 of device 100 does not have any valve conventionally.Do not have a benefit of valve to be that capsule part 103 can expand as much as possible as required or shrink, to help reset and the location of fracture.Capsule part 103 does not have another benefit of valve to be effect and the safety of device 100.Due to the communicating passage not having from reinforcement material to health, thereby material seepage that can be not any, because all materials are all contained in capsule part 103.In one embodiment, between capsule part 103, form permanent seal, sealing was hardened and is attached before delivery conduit 110 is removed.Because all embodiments are not intended to be limited to this mode, therefore capsule part 103 can have valve.

The diameter range of the capsule part 103 of delivery conduit 110 is that about 5mm is to about 9mm.The length of the capsule part 103 of delivery conduit 110 is that about 20mm is to about 80mm.In one embodiment, capsule part 103 has the length of diameter and the about 30mm of about 5mm.In one embodiment, capsule part 103 has the length of diameter and the about 40mm of about 5mm.In one embodiment, capsule part 103 has the length of diameter and the about 30mm of about 6mm.In one embodiment, capsule part 103 has the length of diameter and the about 40mm of about 6mm.In one embodiment, capsule part 103 has the length of diameter and the about 50mm of about 6mm.In one embodiment, capsule part 103 has the length of diameter and the about 30mm of about 7mm.In one embodiment, capsule part 103 has the length of diameter and the about 40mm of about 7mm.In one embodiment, capsule part 103 has the length of diameter and the about 50mm of about 7mm.

In one embodiment, reinforcement members 105 is surrounded the slender axles 101 of delivery conduit 110, and provides rigidity on slender axles 101.Propeller or regulator 116 can be loaded near capsule part 103.Sliding sleeve 107 can surround reinforcement members 105.In one embodiment, sliding sleeve 107 is from the near-end 123 of capsule part 103 until propeller 116 all surrounds reinforcement members 105.One or more radiopaque labellings or be with 130 can be arranged in various positions along capsule part 103 and/or sliding sleeve 107.Radiopaque black pearl 133 can be arranged on the far-end 121 of capsule part 103, for the aligning at fluoroscopy process device 100.Use radiopaque material such as barium sulfate, tantalum or known to be with 130 for increasing the one or more radiopaque of other materials of radiopacity, allow medical professional to watch device 100 by fluoroscopy technology.This is one or more radiopaque with 130 visualitys that also provide in the expansion process of capsule part 103, to determine capsule part 103 and the exact position of installing 100 in placement and expansion process.These one or more radiopaque any spaces that formed by the air entering in capsule part 103 of can seeing with 130 permissions.These are one or more is radiopaquely with this visuality of 130 permission, to prevent that capsule part 103 from not engaging or not contacting skeleton due to non-suitable expansion, with the capsule/bone interface being consistent.

In one embodiment, adapter 115 (for example Tuohy-Borst adapter) engages with the near-end 102 of delivery conduit 110.The light pipe 152 having for transmit the adapter 150 of light from light source (not shown) can be introduced into a side arm of adapter 115, and passes through in the interior lumen of delivery conduit 110.In one embodiment, this light pipe 152 is optical fiber.This optical fiber can be made up of any material, for example combination of glass, silicon, fused silica, quartz, sapphire, plastics or material, or any other material, and can there is any diameter.In one embodiment, the wide angle light scattering of about 88 degree is made up and can be had to described optical fiber of fused silica.In one embodiment, described optical fiber is made up of plastic material.The adhesive system that holds reinforcement material be directed in another side arm of adapter 115, as shown in Figure 2 B.Alternatively, road strategic point (Luer) joint can engage with the near-end of delivery conduit 110 102, and strategic point joint in road will be present on light pipe 152, thereby delivery conduit 110 and light pipe 152 will lock together.

The example of adhesive system includes but not limited to, the caulking gun type systematic, syringe system, the skeleton bag system that comprise skeleton reinforcement material, wherein control the conveying of skeleton reinforcement material with pipe clamp or any other choke valve.In the embodiment shown in Fig. 2 B, adhesive system is syringe 160.In one embodiment, syringe 160 has the controlling organization of the flow of adjustable rooting material.The controlling organization of syringe 160 allows reinforcement material to flow into elm and send conduit 110, can stop this inflow and if need.Syringe 160 carries out directly contact to control the directed flow of reinforcement material, and the flow direction of reinforcement material immediately changes in delivery conduit 110 in response to the variation of the direction of syringe 160.

In one embodiment, syringe 160 is opaque and does not allow light to penetrate in syringe 160.The reinforcement material that opaque syringe 160 is guaranteed to be included in syringe 160 can not be exposed to light and can in syringe 160, not solidify.In the time measuring with dynamic viscosity unit's centipoise (cP), reinforcement material has certain liquid consistency, and therefore reinforcement material can inject delivery conduit 110 and inject capsule part 103 from syringe 160.Because reinforcement material has liquid consistency and glues, therefore reinforcement material can be carried by low-pressure delivery, and does not need high-pressure delivery, but also can use high-pressure delivery.

In one embodiment, reinforcement material is Photocurable adhesive or ultraviolet (UV) binding agent.The example of photo-curing material comprises can be from being positioned at those materials that happy safe (Loctite) of Henkel Corp. of Connecticut State Rocky Hill buy and those materials that can buy from being positioned at the DYMAX company of Connecticut State Tuo Lingdun.The benefit of ultraviolet curing is that it is one solidification process as required, and those binding agents may be not containing solvent and comprise the resin of environmental sound, these resins one are exposed to long wave ultraviolet light or visible ray will solidify in several seconds.Different ultraviolet binding agents uses ultraviolet to different range and the light trigger of visible ray sensitivity.Ultraviolet light energy is very high, therefore can destroy valence bond, makes molecule abnormality and enlivens or make molecular ionization, normally changes their interbehavior.Visible ray, but for example visible blue light, allows material in block ultraviolet for example transmits, between the base material (plastics) of visible ray to solidify.Visible ray penetrates binding agent and arrives the larger degree of depth.Because visible ray penetrates binding agent, therefore in the time that the more parts of electromagnetic spectrum can be used as useful energy, the curing increase of binding agent.Additive can use together with ultraviolet adhesive conveying system, includes but not limited to medicine (for example antibiotic), protein (for example somatomedin) or other natural or synthetic additives.

The scope of electromagnetic spectrum is all possible electromagnetic radiation.The electromagnetic spectrum of object is the frequency range of the electromagnetic radiation of object transmitting, reflection or transmission.Electromagnetic spectrum, from just extending to gamma-rays (in short wavelength's end) lower than modern radio frequency used (in long wavelength's end), has covered the wavelength that drops to the mark of atomic size from several thousand kms.In one embodiment, ultraviolet binding agent is one pack system, not solvent-laden binding agent, this binding agent can not solidify until ultraviolet lighting is mapped on binding agent, and when this happens, binding agent will solidify the complete combination that has shear strength to form in several seconds.In one embodiment, contraction when reinforcement material can demonstrate about 2% to about 3% in the time solidifying.

Ultraviolet wavelength scope is from about 1nm to about 380nm, and can be divided into following kind again: nearultraviolet rays (380-200nm wavelength; Be abbreviated as NUV), far away or vacuum ultraviolet (200-10nm; Be abbreviated as FUV or VUV) and extreme far ultraviolet rays (1-31nm; Be abbreviated as EUV or XUV).Similarly, the wavelength spectrum of visible ray arrives between about 780nm at about 380nm.It will be recognized by those skilled in the art that some ultraviolet binding agents can activate with ultraviolet light, visible ray, X ray, gamma-rays, microwave, radio wave, long wave, or with its wavelength be less than about 1nm, at about 1nm and approximately between 380nm, at about 380nm with approximately between 780nm or be greater than any photoactivation of 780nm, but not every embodiment is all intended to limit this respect.

Use ultraviolet light, reinforcement material just guarantees not have thermal output or thermal output minimum, and thermal output can not last long.More particularly, there is no chemical combination or the mixing of material.Solidifying reinforcement material with ultraviolet light contributes to knochenbruch to keep going up in position, filling capsule part and observe under C arm imaging system.Reinforcement material solidifies in this mode that is enough to skeleton to remain in correct orientation.More particularly, can before make reinforcement material sclerosis, just can expand to skeleton, arrange, adjust, determine the connection of orientation and final bone.Light trigger is actuated in the introducing of ultraviolet light, the sclerosis of ultraviolet binding agent.Once ultraviolet light is introduced into, just sclerosis of the binding agent in capsule part, and inner binding agent is fixed and goes up in position.Until ultraviolet light is introduced into, the placement of skeleton can not be interfered or complete with precipitate haste, because binding agent is until light is introduced into Shi Caihui sclerosis, because the viscosity capsule part of binding agent can expand or shrink.Due to the low viscosity of binding agent, binding agent can be injected in capsule part or from capsule part and separate.In one embodiment, the viscosity of reinforcement material is about 1000cP or less viscosity.In one embodiment, the range of viscosities of reinforcement material is from about 650cP to about 450cP.Not all embodiment is all intended to limit this respect, and some embodiment can comprise that viscosity is accurately equal to or greater than the reinforcement material of 1000cP.In one embodiment, radiography material can be added in reinforcement material, and can not increase significantly viscosity.Radiography material includes but not limited to barium sulfate, tantalum or other radiography materials known in the art.

Epoxy resin more known in the art are suitable for use as skeleton reinforcement material, and in viscosity, hardening time and hardness (durometer hardness or Shore hardness), are different in the time solidifying completely.The hardness of the durometer hardness instruction material of material, this hardness is defined as the drag of material to residual indentation.According to the amount of the required comprehensive support of specific fracture, can select the ultraviolet binding agent of special durometer hardness.Alternatively, the multiple ultraviolet binding agent that can select to have different durometer hardnesses is for repair of bone fractures and in the scope and spirit of disclosed embodiments of the present invention.Can change the durometer hardness of material to realize larger rigidity or to have the result that has more ductility.The mechanical performance of epoxy resin can utilize typical case to determine for high strength and high method/measurements of resisting material, includes but not limited to hot strength and stretch modulus, hot strength test, limiting modulus, Poisson's ratio (Poisson ' s ratio), simply supported beam impact (Charpy Impact) measured value as hardness measurement value and measurement yield strength and the toughness of Vickers hardness.

In one embodiment, reinforcement material solidifies by chemokinesis or hot activation.Chemical activator includes but not limited to water or other liquid.In one embodiment, reinforcement material is to have the dry adhesive that is dissolved in the polymer in solvent, and therefore, in the time that solvent evaporates, binding agent hardens.In one embodiment, reinforcement material is heat or thermoplastic cements, and therefore, in the time of adhesive cools, binding agent hardens.

Reinforcement material is not limited to embodiment as described herein, and can be any material of reinforcing skeleton.Some material can require by via any-mode, for example, by ultraviolet light or visible ray, heat and/or increase or remove compound or material solidifies or by curing enhancing like this, can utilize any outside or internal procedure to carry out curing materials, or may not need to solidify.

In one embodiment, CNT (CNT) is added in reinforcement material, to improve the intensity of material.CNT is the allotrope of carbon, and it is taked the form of cylindrical carbonaceous molecule and has novel strength character.CNT demonstrates outstanding intensity.CNT is the member of fullerene structure family, and this family also comprises buckyball.But buckyball is spherical form, CNT is that it is at least typically coated with the cylinder of the hemisphere of buckyball structure in one end.CNT is all made up of sp2 key, is similar to the situation of graphite.This provides unique intensity than the more fastening bond structure of the sp3 key of finding in diamond for molecule.CNT is aligned to self them " rope " that keep together natively by Van der Waals force.SWCN or multi-walled carbon nano-tubes can be used for strengthening reinforcement material.

The junction point of Disengagement zone between near-end 123 and the slender axles 101 of capsule part 103. Disengagement zone also can comprise light band.In the time activating, light band makes light be cured the reinforcement material of the capsule part 103 that is arranged in light band.Light band extends around delivery conduit 110, and has area of stress concentration.Area of stress concentration can be recess, groove, raceway groove or the similar structures that makes the stress concentration in light band.The area of stress concentration of light band can be by notch cutting, beat indentation, cut a notch, weaken in advance or prestress, to capsule part 103 is directly separated under specific torsional load with the slender axles 101 of delivery conduit 110.Disengagement zone guarantees that reinforcement material can be from the slender axles of delivery conduit 110 101 and/or capsule part 103 seepages.Disengagement zone sealed bladder part 103, and by for example, disconnecting at known or preposition (Disengagement zone) slender axles 101 that remove delivery conduit 110.Disengagement zone can be all lengths, and the longest is about 1 inch.In the time that moment of torsion (torsion) is applied to delivery conduit 110, slender axles 101 separate from capsule part 103.This torsion produces enough large shearing force, to disconnect remaining reinforcement material and to be formed on the clean separation at capsule/axle interface.Light band can be connected to light source and can be activated by independent switch.Activating light band with unique switch can help prevent light to transmit unintentionally and curing reinforcement material from light pipe.The end of the activation sealed bladder part 103 of light band and sealing delivery conduit 110, and guarantee at light band place it is reinforcement material " sealing firmly ", do not allow reinforcement material from capsule part 103 or delivery conduit 110 seepages.

Fig. 3 A, Fig. 3 B and Fig. 3 C show in disclosed embodiments of the present invention for repairing the close up view of embodiment of some critical pieces of the device 300 that weakens skeleton or fractured bones.One or more radiopaque labellings or be arranged on various positions with the sliding sleeve 307 of 330 delivery conduits 310 along device 300.Those skilled in the art will recognize that radiopaque labelling 330 also can be arranged on various positions along the capsule part 303 of device 300.In one embodiment, this one or more radiopaque length with 330 sliding sleeves 307 along device 300 is arranged with the interval of about 10mm.In one embodiment, radiopaque black pearl 333 is arranged on the far-end 321 of capsule part 303, for easily observing and alignment device 300 in the time repairing operating process in fluoroscopy.Radiopaque labelling 330 and radiopaque black pearl 333 are used radiopaque material, such as barium sulfate, tantalum or known to the other materials of increase radiopacity make.It is visual that this radiopaque labelling 330 provides in the expansion process of capsule part 303, to determine the exact position of capsule part 303 and delivery conduit 310 in placement and expansion process.This radiopaque labelling 330 allows to see the space being formed by the air that may enter in capsule part 303.This radiopaque labelling 330 allows this visuality, to prevent that capsule part 303 from not engaging or not contacting skeleton due to non-suitable expansion.Once determine the tram of capsule part 303 and delivery conduit 310, the near-end of delivery conduit 310 just can be attached in the induction system that comprises reinforcement material.

Along the cutaway view of the line A-A of Fig. 3 A shown in Fig. 3 B.As shown in Figure 3 B, the slender axles 301 of delivery conduit 310 end at the capsule part 303 with outer surface 322.It in the slender axles 301 of delivery conduit 310, is the light pipe conduit 311 for receiving light pipe (not shown).The space 313 that is used as the passage of reinforcement material is formed between the inner surface 324 of delivery conduit 310 and the outer surface 317 of light pipe conduit 311.The induction system that comprises reinforcement material can be attached to the side arm of Tuohy-Borst adapter, and this Tuohy-Borst adapter is engaged to the near-end of delivery conduit 310.Reinforcement material can and enter capsule part 303 by the space of delivery conduit 310 313.The injection of reinforcement material makes capsule part 303 expand into the expectation state.In one embodiment, reinforcement material injects by the space 313 in delivery conduit 310, thereby so that capsule part 303 expand by skeleton be positioned at healing orientation on.In order to establish healing orientation, capsule part 303 expands always until skeleton moves to alignment orientation supported.The orientation of skeleton can be carried out in the situation that this process not being carried out any visible observation or do not used X ray or fluoroscope.In one embodiment, C arm imaging system is used as a part for fluoroscope.This C arm imaging system can allow fluoroscope to move in the time observing or operate to rotate around tissue.Can monitor or check by other technologies the expansion of capsule part 303, for example nuclear magnetic resonance of these technology (MRI), ultrasonic imaging, XRF, fourier transform infrared spectroscopy, ultraviolet or visible light method.Capsule part 303 can be made up of nonferromugnetic material, therefore with MRI compatibility.

Cutaway view along the line B-B of Fig. 3 A is illustrated in Fig. 3 C.As shown in Figure 3 C, slide outside sleeve 307 surrounds reinforcement members 305.Reinforcement members 305 is surrounded the slender axles of delivery conduit 310 and is provided rigidity to it.Light pipe conduit 311 provides the space of passing through to light pipe.Space 313 is formed between the outer surface 317 of light pipe conduit 311 and the inner surface 124 of delivery conduit 310.This space 313 provides passage to reinforcement material.The outer surface 317 of light pipe conduit 311 has been considered the separation between light pipe and reinforcement material.

Fig. 4 show with in disclosed embodiments of the present invention for repairing the embodiment of the light pipe 452 using together with the device that weakens skeleton or fractured bones.Light pipe 452 is connected with light source (not shown) by adapter 450.The reinforcement material of the capsule part of the delivery conduit that light pipe 452 injects this device for hardening.In the embodiment described in Fig. 4, light pipe 452 ends at optical lens 454.The energy of launching from light pipe 452 penetrates by optical lens 454, and is imported into the capsule part of the delivery conduit of this device.Optical lens 454 can be protruding, recessed or plane.The energy sending from light pipe 452 can be assembled or disperse to optical lens 454.In one embodiment, optical lens 454 is made up of plastic material, for example acrylic acid of described plastic material (PMMA), Merlon (PC), polystyrene (PS) or other similar materials well-known to those skilled in the art, such as cyclic olefine copolymer (COC) and amorphous polyolefin (Zeonex).In one embodiment, optical lens 454 is by making such as quartzy glass material.

Light pipe 452 is introduced in the side arm of the adapter engaging with the near-end 102 of the delivery conduit of this device.Light pipe 452 is the slender axles through the delivery conduit 110 of this device by light pipe conduit.In one embodiment, described light pipe 452 will be arranged in light pipe conduit so that it is arranged in the Disengagement zone of this device.The junction point of Disengagement zone between far-end and the slender axles of capsule part.The activation going down light of the light source being connected with light pipe 452 by adapter 450 to light pipe 452 so that reinforcement material solidify, thereby cause capsule partial fixing at expansion shape.Solidify and can refer to any chemistry, physics and/or mechanical transition, this transformation allows compositions for example, from (allowing its form of passing through the space conveying delivery conduit, flowable form) make progress into finally for example, for more lasting (, the solidifying) form in body.For example, " curable " can refer to uncured compositions, this uncured compositions (when by catalysis or while applying the suitable energy) likely solidify in vivo, also can refer to the compositions (compositions for example, forming by mixing in multiple combination thing composition) in solidification process in the time carrying.

Fig. 5 A and Fig. 5 B show the side sectional view for the embodiment of some critical pieces of the device of repair of bone fractures skeleton, and described device has by the light pipe 452 of Fig. 4 of the light pipe conduit 511 of the slender axles 501 of this device.Light pipe 452 transmits light for the capsule part 503 to this device, and injects the reinforcement material of the capsule part 503 of this device for hardening.The energy sending from light pipe 452 sends by optical lens 454, and is imported in capsule part 503.Optical lens 454 can be protruding, recessed or plane.The energy sending from light pipe 452 can be assembled or disperse to optical lens 454.

Fig. 6 show with in disclosed embodiments of the present invention for repairing the embodiment of the light pipe 652 using together with the device that weakens skeleton or fractured bones.Described light pipe 652 is connected with light source (not shown) by adapter 650, unlike the light pipe 452 described in Fig. 4.Light pipe 652 does not end in optical lens.Light pipe 652 is connected with light source (not shown) by adapter 650.The reinforcement material of the capsule part of the delivery conduit that the light of being launched by light pipe 652 is injected into this device for hardening.The energy of being launched by light pipe 652 is directed in the capsule part of delivery conduit of the device in disclosed embodiments of the present invention.

Light pipe 652 is introduced in the side arm of the adapter engaging with the near-end of the delivery conduit of this device.Light pipe 652 is the slender axles through the delivery conduit of this device by light pipe conduit.In one embodiment, described light pipe 652 will be arranged in light pipe conduit so that it is arranged in the Disengagement zone of this device.The junction point of Disengagement zone between near-end and the slender axles of capsule part.The activation going down light of the light source being connected with light pipe 652 by adapter 650 to light pipe 652 so that reinforcement material solidify, thereby cause capsule partial fixing at expansion shape.Solidify and can refer to any chemistry, physics and/or mechanical transition, this transformation allows compositions for example, from (allowing its form of passing through the space conveying delivery conduit, flowable form) make progress into finally for example, for more lasting (, the solidifying) form in body.For example, " curable " can refer to uncured compositions, this uncured compositions (when by catalysis or while applying the suitable energy) likely solidify in vivo, also can refer to compositions in solidification process (for example, in the time carrying by multiple thin compound composition in the compositions that forms of mixing).

In one embodiment, device for repair of bone fractures skeleton comprises: the delivery conduit with slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of light pipe, and wherein the far-end of interior lumen ends at optical lens; Conformal member, described conformal member engages the far-end of delivery conduit in detachable mode, and wherein, in the time that at least one reinforcement material is transported to described conformal member, conformal member moves to swelling state from contraction state; And adapter, described adapter engages the near-end of delivery conduit in detachable mode, for receiving described light pipe and described at least one reinforcement material.Fig. 7 shows the side sectional view for the embodiment of some critical pieces of the device 700 of repair of bone fractures skeleton.Device 700 comprises the delivery conduit 710 with slender axles 701, and described slender axles 701 have light pipe conduit 711.Light pipe conduit 711 holds the light pipe 652 of Fig. 6.As shown in Figure 7, device 700 is arranged in shell 750.Light pipe 652 is for transmitting luminous energy to device 700 conformal member 703, and makes to be injected into the reinforcement material sclerosis in the conformal member 703 of device 700 by internal voids 713.The energy of being launched by light pipe 652 penetrates by the optical lens 754 of the far-end 723 of engagement light pipe conduit 711, and is directed in conformal member 703.Optical lens 754 is passed to conformal member 703 by luminous energy from light pipe 652.For clarity sake, Fig. 7 shows optical lens 754 has certain distance with described light pipe 652.But conventionally in use, light pipe 652 adjoins optical lens 754.Optical lens 754 can be protruding, recessed or plane.The luminous energy sending from light pipe 652 can be assembled or disperse to optical lens 754.The luminous energy transmitting makes the reinforcement material sclerosis in conformal member 703.

In some embodiments, light intensity can be enough to arrive the far-end of conformal member (for example capsule part), for example, if light pipe (optical fiber) keeps very close with conformal member, or contacts/adjoin conformal member.By known curing reinforcement material or the required energy of polymerization single polymerization monomer and calculate the distance of described light pipe to the distal-most end direction of conformal member, inverse square law can be used for calculating the energy that dissipates at this segment distance number, therefore determine whether light pipe can adjoin and maybe need to be placed in conformal member so that more contiguous reinforcement material with conformal member.In conformal member, not only make the Distance Shortened of light pipe to reinforcement material by light pipe is placed on, and can reduce all essential light intensities.

In one embodiment, device for repair of bone fractures skeleton: comprise the delivery conduit with slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, and described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of optical fiber; Conformal member, described conformal member engages the far-end of delivery conduit in detachable mode, described conformal member has the interior lumen for receiving described optical fiber, wherein, in the time that at least one reinforcement material is transported to described conformal member, conformal member moves to swelling state from contraction state; And adapter, described adapter engages the near-end of delivery conduit in detachable mode, for receiving described optical fiber and at least one reinforcement material.

Fig. 8 shows the perspective view of the embodiment of light pipe, described light pipe be with in disclosed embodiments of the present invention for repairing the optical fiber 852 using together with the device that weakens skeleton or fractured bones.In some embodiments, can use and be similar to LUMENYTE STA-FLEX SEL and hold the optical fiber of luminous Optical Fiber (deriving from Lumenyte International Corporation of Foothill Ranch, CA).These optical fiber separately can by pass light solid large core, covering and black binding type oversheath composition.Optical fiber 852 can be sent to the outfan 854 as point source from light source by light.Optical fiber 852 can have wide 80 degree acceptance angles and 80 degree beam divergences, allows light from more oblique angles.Passing light core diameter can be solid, can have without dim light packing fraction loss and can easily splice.This sheath can be adhesion.The sheath of customization can be used for more flexible and color selection.

Optical fiber 852 can have separately lower than transmission loss (decay), about 6 times of bending radius to optical fiber 852 diameters (minimum) of every foot about 1.5%, reach the stability of about 90 DEG C (194 °F), approximately the spectrum of 350-800nm transmit scope, about 80 ° accept angle, about 1.48 or higher refractive index core, about 1.34 or covering (cladding) still less and about 0.63 numerical aperture.The length of fiber 852 can be about 100 continuous feet.In this area, can use splicing for example Lumenyte Splice Kit of external member (splice kit) and realize splicing according to technical instruction carefully.Shop splice can be to select.Can advise that for example Lumenyte ' s Optic Cutter of optics cutting machine cuts for straight line, cleaning, 90 ° of fibers.Can these fibers be installed by the oversheath (non-fluorinated polymer covering) that removed about 4 inches (10cm) before fiber 852 is inserted into light source.The end 850 of fiber 852 can be close to but not contact luminous organ (illuminator) (light source) glass, to contribute to realize high-high brightness.In some embodiments, optical fiber 852 has the ESKA being manufactured by Mitsubishi Rayon company limited ^tMhigh-performance Plastic Optical Fiber:SK-10 and SK-60 and/or ESKA ^tMsome or all of character and/or feature that Plastic Fiber Optic & Cable Wiring shows, they all derive from Mitsubishi International Corporation of New York, NY.The above-mentioned feature and the character that it should be understood that described optical fiber are exemplary, and not every embodiment of the present invention is all intended to be limited to these aspects.

In order to have optics and mechanical advantage, optical fiber uses the structure of concentric layer.The most basic function of fiber is direct light, although keep light in longer propagation distance, concentrate-natural being tending towards of light beam disperse, and under strong bending condition also may direct light.Under the simple case of step index fiber, realize in this region that creates the refractive index with increase that is guided through around fiber axis (being called fibre core), described region by covering institute around.Covering is by using at least one layer of polymeric coating protection.By total internal reflection, light is remained in " core " of optical fiber.Covering makes light advance and arrive at the destination along fibre length.In some cases, expect along single-rail conduction electro-magnetic wave and along guide's far-end of given length instead of only extract light at guide's terminal area.In certain embodiments of the invention, for example, by removing covering, at least a portion of fiber lengths is modified, to change direction of light, propagation, amount, intensity, angle of incidence, uniformity and/or distribution.

Fig. 9 A-9E shows the close-up perspective view of the illustrative embodiment of the modification to fiber lengths of disclosed embodiments of the present invention.In embodiment in shown in Fig. 9 A-9E, described optical fiber is modified to change direction of light, propagation, amount, intensity, angle of incidence, uniformity, disperse and/or distribute.In one embodiment, described optical fiber is modified so that disperse described luminous energy along at least a portion of described fiber segment.In one embodiment, dispersing luminous energy along described fiber segment is to realize by the surface of described optical fiber is modified.In one embodiment, luminous energy betides radial direction from dispersing of described optical fiber.As shown in the embodiment as described in Fig. 9 A, can form or cut out annular step (902,904 and 906) in optical fiber 900 of the present invention so that light is dispersed along each terminal area 903 of the each annular step (902,904 and 906) of optical fiber 900.In some embodiments, preferably remove optical fiber of the present invention covering some, all or part of.As shown in the embodiment of Fig. 9 B, optical fiber 91 (be tapered along length, and some covering removes.Being tapered of optical fiber 910 can cause light radially to be dispersed from optical fiber 910.As shown in the embodiment as described in Fig. 9 C, can cut out recess 921 so that the angled sensing of recess 921 in internal reflection and fiber 920 is outside to optical fiber 920.In some embodiments, recess can become about miter angle place to form with fiber.In some embodiments, recess can or be less than about 45 degree or be greater than approximately 45 any angles formation of spending with about 30 degree angles, about 62.5 degree angles, is not that all embodiments of the present invention are intended to be limited to this mode.In addition, in some embodiments, the angle of recess can change along the residing position of fibre length with recess.For example, optical fiber can be by notch cutting to be arranged on the angle of recess of capsule end more shallow than the angle that is arranged on capsule center.In some embodiments, the end of the single optical fiber of formation fibre bundle can interlock to make light launch from light source at the diverse location along fibre length.In some above-mentioned embodiment, by light laterally or is radially advanced in capsule, the light shorter distance that only needs to advance just can arrive glue.As shown in the embodiment as described in Fig. 9 D, by form helical form pattern along one section of optical fiber 930, one of optical fiber 930 section of covering is modified.As shown in the embodiment described in Fig. 9 E, remove a part for covering 942 from optical fiber 940.

In some embodiments, optical element can with described optical fiber in recess or register orientation regulate light output.This type of optical element can comprise lens, prism, light filter, beam splitter (spliter), diffuser and/or holo film.Light source, more specifically, optical fiber can have U.S. Patent No. 6,289, listed some or all of character and feature in 150, this patent thus by reference entirety be incorporated to herein, although be not that all embodiments of the present invention are intended to be limited to these aspects.

In some embodiments, described optical fiber can comprise by the fiber cores of encompasses and one or more luminous organ.Luminous organ can have uniform size and dimension, arranges with mode straight line that be scheduled to, interval along a side of described fiber cores.Described fiber cores can receive in the track and/or clamper and/or reflector that comprises passage, and described passage is built with and reflective inner surface centered by luminous organ.Clamper and/or reflector can be arranged on contiguous multiple luminous organs place or contact with multiple luminous organs.Light source can be connected to one end of fibre-optic catheter in a conventional manner to cause TIR effect.End at the fibre-optic catheter on light source opposite can comprise the reflecting surface for any luminous reflectance that is retained in fibre-optic catheter being got back to light source.For longer optical catheter span, conduit can comprise secondary light source.

Luminous organ can be included between processing period or be building up to afterwards in fiber cores and any inhomogeneities of reflection or refracted light, for example, between processing period or the bubble forming in core afterwards, prism, lens or reflecting material.Equally, make to remove the recess of wedge of material or can be used as luminous organ by the single otch making in core by two otch in core.Luminous organ (for example recess or otch) can be by making with mechanical cutter, described mechanical cutter can cut equably core and stay next level and smooth, without the surface of texture.The sickle that is applicable to this object can cut core and not tear or burn out material.Sickle can have discoid cutter, and this cutter has level and smooth, the anodontia blade that can rotate freely around the axle that is positioned at disk center.This blade can become miter angle cutting 90 degree recesses with respect to the longitudinal axis of core, wherein has crescent or leg-of-mutton material and removes from core.

This recess can be by making the TIR effect of light of in-core maximize the effect of luminous organ.This may be because described core has different refractive indexes in the surrounding air of recess, and this recess can pass light guiding through core and from the offside of core.Different photo effects can be by replacing surrounding air to realize with other gases or compound.The defect of otch can guide some light to enter recess.This light can reflect by core.

, can enter the even depth of 1/8 inch of covering and core and become miter angle to make otch with the longitudinal axis that is optical fiber with horizontal plane preferably in the embodiment of some on recess at otch.It seems that this can make light pass perpendicular to the longitudinal axis of described optical fiber, and what wherein fiber cores can have about 81 degree accepts angles to allow light to pass.The surface of the both sides of this otch can be level and smooth instead of coarse, to guarantee refracted light equably.This otch can form chock, and this chock has is enough to prevent the interval that contacts between otch both sides in normal use procedure.This contact can reduce luminous reflectance and/or refractive properties.In some embodiments, rely on TIR with force light pass core aspect, the efficiency of this otch is a little less than recess.Can also can be used as clamper and/or reflector with the clamper of the fixing described optical fiber of required alignment thereof.In some embodiments, in the time that the cross section of optical fiber is circular and for example can be placed on, in nonuniformity clamper (producing straight line " U " passage of open space in " U " bottom), can in optical fiber, make otch, it is close to maintain this configuration with " U " bottom.In some embodiments, in the time can using concordance clamper, otch can be close to and change configuration, to such an extent as to can reduce light extraction efficiency.In some embodiments, in the time using concordance clamper, can make the jagged luminous organ of tool, this notched foot is to maintain the open space between clamper and notch cutting surface.

In some embodiments, cutting recess can comprise that using the high-speed drilling electromotor with cutting edge, this cutting edge to be enough to cut out recess in optical fiber can enough smoothly occur with permission total internal reflection with the surface that uses indent reason.Luminous organ can be determined the directivity of the light output of being launched by optical system with respect to the alignment of clamper.The shape of otch can affect the output bundle type of optical system.For example, otch is wider, and output bundle type is wider.

The same with most of linear fibre optics, along with the fibre length from close to sources is extracted light, after can be used for, the light of section may be less, and consider possibly in process of production this event.In some embodiments, in order to obtain uniform illumination from described fibre-optic catheter, the frequency that luminous organ occurs can the non-linear increase of distance from light source with respect to catheter length and luminous organ.In other words,, in the time that the distance from light source increases, luminous organ can draw closer together each other.This can compensate the decay of the caused light of loss being experienced by luminous organ and the natural attenuation of optics self.Can make spacing draw closer together gradually, or can make spacing be divided into some groups, wherein each group can draw closer together gradually, but in every group, the distance between single luminous organ can remain unchanged.In some embodiments, luminous organ can be gradually dark, so that optical fiber is along its length transmission light coequally.In the time that prepared luminous organ is gradually dark, may change light image.Otch is darker, and it is wider that light image becomes.In the time that prepared luminous organ is asymptotic, light image can keep identical and can increase light output.In some embodiments, can realize and be close to uniform light output along catheter length, this part be the variation because of the spacing of luminous organ, in part because the size of luminous organ and the uniformity of angle.Mechanical cutter can be suitable for providing this uniformity well.

Although some embodiment can comprise the continuous variation of the frequency of otch spacing, sickle can be suitable for changing with discontinuous interval the frequency of spacing so that intervals phase of adjustment between delay minimization.

Can add in fiber cores, make separately before covering luminous organ and/or can core by covering around after in covering and core, make luminous organ.In some embodiments, when covering is heated so that its while being contracted in the surrounding of core tightly, covering can affect the uniformity of luminous organ in core by the light deflection character that enters recess or close incisions and reduce thus possible luminous organ.

Luminous organ can be arranged to direct light through the larger diameter of ellipse-shaped light fibre core and pass by the region relative with each luminous organ separately.This can by making, recess and/or notch shape are angled to be realized through optical core from the light of light source with guiding.Luminous organ allows to control better the escape of light by cutting out recess, the side that this recess is arranged on optics is with direct light instead of allow otch with various direction reflection/refracted lights, and this makes light reduce the contribution of required focusing effect.

Also can increase one or more optical elements alone or in combination (for example diffuser, polarizer, amplifying lens, prism, hologram or any other can change the element of direction, quantity or the quality of illumination), and this optical element and core-covering, recess and track or clamper and/or reflector are alignd.Optical element can form or form with core, covering and/or sheath material entirety with separate part, or forms with the combination in any of independent and integrally formed parts.The optical element that entirety is formed in core and the covering of various shapes can form lens, and affects thus the direction of light from finished product.Different fiber shape can form different output bundle types.In some embodiments, round fiber can form wider beam spread.In some embodiments, wedge shape optics can produce collimated beam diffusion.This bundle diffusion may be to be the result of lens effect owing to it is believed that.In some embodiments, the degree of depth of otch at least can be crossing with the focus of the lens that formed by the curvature that passes the fiber cores of the position of core at light.

Described fiber cores can have any shape, and the shape of core can affect dispersing of light.In some embodiments, described fiber cores can be cylindrical when with cross-sectional view, and can be formed on the lens of diverging light in wide surround.In some embodiments, described fiber cores can have avette or oval when with cross-sectional view, and can in narrower surround, form the lens that increase light intensity.In some embodiments, described fiber cores can have wedge shape when with cross-sectional view, and can form lens.It should be understood that and can use other shape, because its required optical characteristics, they also can be used as optical element, although be not that all embodiments of the present invention are intended to be limited to this respect.

Substituting optical element also can help realize various illumination effects, by comprise the independent optical element aliging with clamper and/or reflector and the arc being formed by recess on the offside of the optics from optical element.Can align lens optics, recess and clamper and/or reflector passes optics and enters lens with direct light.Also can in sheath material, integrally form optical element.Can regulate jacket thickness to realize required illumination effect.Alternatively, columniform diffuser can be included and be alignd to produce other required illumination effect.In some embodiments, the first diffuser can reduce the light intensity by optical fiber, and the second diffuser can increase the light intensity by it.Therefore,, in the time that light transmits and disperses from optical fiber, two kinds of diffusers describing thus can be revised light intensity.

In order to utilize better this application specific illumination optical, can suitably control aliging of luminous organ, clamper and/or reflector and optical element.In some embodiments, the alignment of these elements can be centered by the diameter of fiber cores (for example, from the center of clamper and/or reflector and perpendicular to the diameter of clamper and/or reflector).Preferably along this alignment of whole fibre-optic catheter length retentive control.

In one embodiment, fracture repair process intensification is not in the case of being exposed skeleton and reinforced weakening skeleton or fractured bones by traditional operative incision.Embodiment of the present invention realize and touch skeleton by making the invasive methods of miniature incision.Invasive methods refers to following modus operandi, for example Miniature surgical, endoscope or Arthroscopic modus operandi, these modus operandis can be realized in the situation that related muscles system being caused to minimum broken ring, for example, do not need to organize the opening of injury site to enter or enter by mini-incision.Micro-operation is conventionally visual by using, and for example fibre optics or photomicrography are realized, and its post-operative recovery time providing is far smaller than the recovery time of following corresponding open surgery method.The benefit of Micro-operation comprise due to lose blood minimum make wound still less, operation and anesthesia duration reduce, time of hospitalization shortens, and more easily and more quickly recovers.In one embodiment, skeletal fixation device can be placed in the intramedullary cavity body that weakens skeleton or fractured bones.By repairing and preserve skeletal structure, some embodiment disclosed in this invention allows following extra treatment to select.

Figure 10 A-10E illustrates the embodiment of the method step for repairing the fractured bones in patient body together with Fig. 1.Skin through patient body cuts out mini-incision (not shown) to expose fractured bones 1002.This otch can be cut at the near-end of fractured bones 1002 or far-end, to expose bone surface.Once skeleton 1002 exposes, may consider skeleton 1002 and some muscle and tissue contracts may must be made.As shown in Figure 10 A, on skeleton, form and enter hole 1010 by boring or additive method known in the art.In one embodiment, the diameter that enters hole 1010 is that about 3mm is to about 10mm.In one embodiment, the diameter that enters hole 1010 is about 3mm.

Enter the skin 1020 that hole 1010 extends through the hard and compact of skeleton and enter inside or the spongiform tissue 1025 of relative porous.For the skeleton with bone marrow, before insertion apparatus 100, should remove the bone marrow material in pulp cavity.Bone marrow is mainly in the flat bone such as hipbone, breastbone, skull, rib, vertebra and scapula, and is being arranged in the spongy material of long bone proximal end of similar femur and humerus.Once arrival pulp cavity, comprises that the bone marrow material of air, blood, fluid, fat, bone marrow, tissue and bone fragments will be removed from space.The space that space is defined as hollowing out, wherein primary importance has defined the distal-most end edge with respect to the space of the penetration site on skeleton, and the second position has defined the most proximal end edge with respect to the space of the penetration site on skeleton.Skeleton can fully be hollowed out so that pulp cavity upwards until the bone marrow material of cortical bone be all removed.In prior art, existed manyly for removing the method for bone marrow material, these methods are all in the spirit and scope of disclosed embodiments of the present invention.These methods comprise those U.S. Patent No.s 4 that is " Method of Suction Lavage " at title, 294, 251, title is the U.S. Patent No. 5 of " Bone Cleaning and Drying system ", 554, 111, title is the U.S. Patent No. 5 of " Apparatus for Preparing the Medullary Cavity ", 707, 374, title is the U.S. Patent No. 6 of " Bone Marrow Aspiration Needle ", 478, 751 and title be the U.S. Patent No. 6 of " Apparatus for Extracting Bone Marrow ", 358, method described in 252.

Wire (not shown) can be introduced in skeleton 1002 via entering hole 1010, and is placed between the bone fragments 1004 and 1006 of skeleton 1002, so that across fracture 1005 position.Wire can be transported in the tube chamber of skeleton 1002 and across the position in crack 1005, to make wire stride across several bone fragments sections.As shown in Figure 10 B, construct and arrange the capsule part 103 of the device 100 for repair of bone fractures skeleton that holds wire, on wire, be transported to fracture 1005 position and stride across the bone fragments 1004 and 1006 of skeleton 1002.Once capsule part 103 is positioned on correct position, wire just can be removed.The position of capsule part 103 can determine with at least one radiopaque labelling 130, and this labelling 130 can detect from the outside of skeleton 1002 or inside.For example, shown in embodiment as described in Figure 10, the radiopaque labelling 130 that uses X ray or other checkout gears to see from health outside arranges along capsule part 103 and the sliding sleeve 107 of delivery conduit 110, to help aligning and positioner 100.Once capsule part 103 is positioned on the tram of fractured bones 1002, device 100 is attached in the induction system that comprises reinforcement material.Reinforcement material injects the also capsule part 103 of access to plant 100 by the space in delivery conduit 110 afterwards.Reinforcement material is joined in capsule part 103 capsule part 103 is expanded, as shown in Figure 10 C.In the time that capsule part 103 is expanded, fracture 1005 resets.In one embodiment, reinforcement material is ultraviolet curing glue, and it requires ultraviolet source to carry out cure adhesive.In one embodiment, in capsule part 103, can retain central space, this central space can be filled to provide extra intensity and support to fractured bones 1002.Optical wand or similar device can be arranged in central space, and are opened or throw light on.Optical wand or similar device can be made up of optical fiber, Silicon stone, quartz, sapphire or similar material.Ultraviolet light will make ultraviolet curing glue harden in capsule part 103 afterwards.The end of optical wand can be cut and remain in capsule part 103, to the rigidity of increase is provided.

Once determine that the orientation of bone fragments 1004 and 1006 is in desired locations, ultraviolet curing glue can for example pass through with the irradiation of ultraviolet transmitting illuminant in the interior sclerosis of capsule part 103, as shown in Figure 10 D.After ultraviolet curing glue hardens, light pipe can remove from installing 100.Once 103 sclerosis of capsule part, can remove it by method well known in the prior art from delivery conduit 110.In one embodiment, cutting delivery conduit 110 is to separate capsule part 103 from slender axles 101.Device slides and allows straight angle shears decline through delivery conduit 110 and form otch on delivery conduit 110.The position of otch can be determined with fluoroscopy or X ray.In one embodiment, the junction point that incision site meets in slender axles 101 and capsule part 103.

In one embodiment, device 100 is for the treatment of hand or Wrist fracture.Wrist is many joints of use and the set portion of skeleton that allows hands.In the time that the strength of grabbing is provided, wrist must be movable.Wrist is very complicated, because each little skeleton and its adjacent bones form joint, therefore wrist comprises at least eight independent little skeletons (being called carpal bone), and these carpal bones are connected two forearm skeletons (being called radius and ulna) on the skeleton of in one's hands and finger.Wrist may come to harm in every way.In the time that injury occurs, some injury seems to be that simple wrist is sprained, but after the several years, problem can seriously be got up.In the time of a bone fracture in the little skeleton of hands, may there is Treat Hand Fracture.Hands is made up of about 38 skeletons, and any one in these skeletons all may rupture.The middle part of palm or hands is made up of metacarpal bone.Metacarpal bone has muscle attachment, and bridge joint wrist and each finger.These skeletons are often due to direct wound and injured, for example pushed by object or more commonly hands run on wall.On joint, be coated with the articular cartilage of Saving cortilage safety.Those skilled in the art will recognize that, disclosed apparatus and method can be for the treatment of the fracture of other skeletons, other skeleton is radius, ulna, clavicle, metacarpal bone, phalanges, metatarsal, phalanx, tibia, fibula, humerus, spine, rib, vertebra and other skeletons for example, and still in the scope and spirit of embodiment of the present invention.

Disclosed embodiments of the present invention can be used for processing clavicular fracture, and clavicle is resetted.Clavicle is classified as the long bone that forms pectoral girdle (shoulder belt) part.The method of existing fixing fracture clavicle is conditional.Clavicle is just in time positioned at skin surface downside, and the probability that therefore comprises the external stability of plate and screw is conditional.In addition, lung and subclavian artery are positioned at clavicle downside, the selection that therefore uses screw not to be.The traditional treatment of clavicular fracture is to aim at knochenbruch and suspender belt is provided and extenuates misery to arm and shoulder by putting it into tram, makes skeleton self healing, and each week or every several week monitor progress with X ray.Here fixing to skeleton not, in the time that the formation of callus and the growth of skeleton link together the skeleton section of fracture, skeleton section combines again.In agglutination, fracture joint portion place has a lot of movements, because not firmly combination, and the formation of callus forms discontinuous point through the fracture of being everlasting.Discontinuous point in neck molding is often caused by clavicular fracture.

Disclosed embodiments of the present invention and method are processed clavicular fracture in Wicresoft's mode, and can be for the reset of clavicle.The benefit of repairing neck with disclosed device is, this reparation makes to repair the dislocation minimum of posterior cervical.The benefit of repairing clavicle with disclosed device has been to alleviate patient's misery in agglutination.

Figure 11 A, 11B and 11C and Figure 12 A, 12B show together with 12C in disclosed embodiments of the present invention for repairing patient's the device 100 of fracture metacarpal bone 1102 of finger 1110 of hands 1100.As shown in the figure, fracture metacarpal bone 1102 splits into two fragments 1104 and 1106 at fracture position 1105.As shown in Figure 12 A, the capsule part of device 100 is transported to the position of fracture 115, and strides across the bone fragments 1104 and 1106 of skeleton 1102.The position of capsule part can determine with at least one radiopaque labelling, and this labelling can detect from the outside of skeleton 1102 or inside.Once capsule part is positioned at the tram of fractured bones 1102, device 100 is attached in the induction system that comprises reinforcement material.Reinforcement material is by the space injection in delivery conduit and the capsule part of access to plant 100 afterwards.Reinforcement material is joined in capsule part and makes the expansion of capsule part, as shown in Figure 12 B.In the time that capsule part is expanded, fracture 1105 resets.In one embodiment, reinforcement material is ultraviolet curing glue, and it requires ultraviolet source to carry out cure adhesive.Ultraviolet light is by the ultraviolet curing glue sclerosis making in capsule part afterwards.In one embodiment, this reinforcement material needs visible light source to carry out curing additive.

Once determine that the orientation of bone fragments 1104 and 1106 is in desired locations, ultraviolet curing glue can for example pass through with the irradiation of ultraviolet transmitting illuminant in the interior sclerosis of capsule part 103.After ultraviolet curing glue hardens, light pipe can remove from installing 100.Once the sclerosis of capsule part, can remove it by method well known in the prior art, as shown in Figure 12 C from delivery conduit.In one embodiment, cutting delivery conduit 110 is to separate capsule part from slender axles.

For the method for repair of bone fractures skeleton, it comprises the inner chamber that enters fractured bones; Be provided for repairing the device of described fractured bones, described device comprises: delivery conduit, described delivery conduit has as the internal voids of the passage of at least one reinforcement material with for receiving the interior lumen of optical fiber, described delivery conduit engages conformal member in detachable mode, and described conformal member has the interior lumen as the passage of described optical fiber; Described conformal member is positioned to at least two skeleton sections crossing over described fractured bones; Described optical fiber is inserted in the interior lumen of described conformal member; Introduce described at least one reinforcement material described reinforcement material is injected in described conformal member by the internal voids of described delivery conduit, wherein said conformal member moves to swelling state from contraction state; Activate the light source being connected with described optical fiber to transmit the interior lumen of luminous energy to described conformal member, thereby make at least one reinforcement material sclerosis; With by sclerosis conformal member remove from described delivery conduit.

All patents, patent application and the published list of references of quoting herein thus by reference entirety be incorporated to herein.Be understandable that, can expect that above more disclosed and other features and function or its replacement are combined in many other different systems or application.Replacement in various current unforeseen or unexpected the present invention, amendment, variation or improve can after realized by those skilled in the art, these are replaced, amendment, change or improvement is intended to be contained by claim below equally.

Claims (13)

1. for a device for repair of bone fractures skeleton, it comprises:

Have the delivery conduit of slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, and described delivery conduit has as the internal voids of the passage of at least one reinforcement material and interior lumen;

Conformal member, described conformal member engages the far-end of described delivery conduit in detachable mode, and in the time that at least one reinforcement material is transported to described conformal member, described conformal member moves to swelling state from contraction state;

Optical fiber, wherein said optical fiber has can be through the interior lumen of described delivery conduit the size that enters described conformal member, and wherein by removing around a part for the covering of described optical fiber, at least a portion of described fiber lengths is modified, and

Adapter, described adapter engages the near-end of described delivery conduit in detachable mode, for receiving described optical fiber and described at least one reinforcement material,

Wherein, in the time that described optical fiber is in described conformal member, described optical fiber can be dispersed luminous energy at terminal area and along the part of the modification of one section of described optical fiber, to cause the sclerosis of described at least one reinforcement material in described conformal member.

2. device claimed in claim 1, wherein said conformal member is made up of polymeric material.

3. device claimed in claim 1, wherein said optical fiber is sent to described conformal member by luminous energy from light source.

4. device claimed in claim 1, it also comprises optical lens, described optical lens is delivered to described conformal member by luminous energy from described optical fiber transmission.

5. device claimed in claim 1, wherein said luminous energy can be dispersed in radial direction.

6. device claimed in claim 1, wherein removes described covering to form helical form pattern on the surface of described optical fiber from described optical fiber, thereby disperses luminous energy with helicon mode at described terminal area and along described fiber lengths.

7. device claimed in claim 1, wherein said at least one reinforcement material is ultraviolet curing glue.

8. device claimed in claim 1, wherein remove described covering with change the direction, propagation, amount, intensity, angle of incidence, the uniformity of described luminous energy or distribute at least one.

9. for a device for repair of bone fractures skeleton, it comprises:

Have the delivery conduit of slender axles, described slender axles have near-end, far-end and the longitudinal axis between far-end and near-end, and described delivery conduit has the internal voids as the passage of Photocurable adhesive, and interior lumen;

Optical fiber;

Conformal member, described conformal member engages the far-end of described delivery conduit in detachable mode, described conformal member has the interior lumen for receiving described optical fiber, wherein, in the time that described Photocurable adhesive is transported to described conformal member, described conformal member moves to swelling state from contraction state; With

Adapter, described adapter engages the near-end of described delivery conduit in detachable mode, for receiving described optical fiber and described Photocurable adhesive,

Wherein said optical fiber has by the interior lumen of described delivery conduit and enters the size of the interior lumen of described conformal member,

Wherein by removing around a part for the covering of described optical fiber, at least a portion of described fiber lengths is modified, and

Wherein, in the time of the interior lumen of described optical fiber at described conformal member, described optical fiber can be dispersed visible luminous energy at terminal area and along the part of the modification of one section of described optical fiber, to cause the sclerosis of the Photocurable adhesive in described conformal member.

10. device claimed in claim 9, it also comprises the light source for described visible luminous energy is provided to described optical fiber.

11. devices claimed in claim 9, wherein visible luminous energy is dispersed in radial direction.

12. devices claimed in claim 9, wherein remove described covering to form helical form pattern on the surface of described optical fiber from described optical fiber, thereby disperse luminous energy with helicon mode at described terminal area and along described fiber lengths.

13. devices claimed in claim 9, wherein remove described covering with change the direction, propagation, amount, intensity, angle of incidence, the uniformity of described visible luminous energy or distribute at least one.